Shielding device and method

ABSTRACT

Some embodiments of a shielding device can include a base and a shield coupled to the base. The shielding device can be used to provide protection for a healthcare worker (e.g., physician, nurse, technician) during a medical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.14/491,499, filed Sep. 19, 2014, which claims the benefit of U.S.Provisional Application Ser. No. 62/028,896, filed Jul. 25, 2014. Thedisclosure of the prior applications is considered part of (and isincorporated by reference in) the disclosure of this application.

TECHNICAL FIELD

This document relates to shielding devices, such as portable radiationshielding devices for use in a medical environment.

BACKGROUND

In many situations, an interventional radiologist or other healthcareworker (e.g., a physician, nurse, technician) may work under a radiationfield (e.g., from a fluoroscope, X-rays, other imaging system, or thelike) when treating a patient. Although significant measures are oftentaken to minimize a patient's exposure to radiation during medicalprocedures, the healthcare worker implementing the procedure is oftenleft exposed to the radiation—at least to some degree—and such exposureis often repeated for each new patient. For example, a healthcareworker's hands can be exposed to radiation from radiation imagingmachines while inserting a central line in a patient (e.g., during afluoroscopic procedure). Physical barriers can be used to shield thehealthcare worker from radiation exposure, but often they are bulky anddisruptive to the healthcare worker during the procedure.

SUMMARY

Some embodiments of a shielding device can be used to provide protectionfor a healthcare worker (e.g., physician, nurse, technician) during amedical procedure. In such circumstances, a shield of the shieldingdevice can be manipulated to a user-selected orientation relative to abase, and optionally, the shield may then locked in the selectedposition so as to provide a radiation block for the healthcare worker'shands that would otherwise be within the radiation field from thereal-time X-Ray imaging apparatus. In addition to the shielding deviceprotecting the healthcare worker's hands from X-Ray radiation, theshield can further provide physical protection for the healthcare workerfrom spatter of blood or other bodily fluids that may occur during theprocedure—all while allowing the healthcare worker to position his orher hands in a non-disruptive and ergonomically effective manner.

In some embodiments, a radiation shielding device may include aradiation shield and a base. The base may include a substructureattachable to an object, and a retainer structure attachable to theradiation shield. Optionally, the base can include a lock device that isactuatable to lock the shield in a selected angular position afteradjusting the shield device relative to the base.

Particular embodiments described herein include a method of shieldingradiation during a medical procedure. The method may include coupling abase of a radiation shielding device to an object proximate a radiationsource. The method may also include coupling a shield of the radiationshielding device to the base. Optionally, the angle of the shieldrelative to the base of the shielding device and the object can beadjusted to a user-selected orientation and then the shield can belocked in place at the selected angular position. The method may furtherinclude shielding radiation from the radiation source as the medicalprocedure is conducted.

In some embodiments, a radiation shielding device includes a radiationshield and a base, and the base may include a substructure attachable toan object, and a retainer structure attachable to the radiation shield.Optionally, the retainer structure may include an adjustable couplingcomprising first and second semi-spherical yokes oriented perpendicularto one another in an overlapping manner. Additionally or alternatively,the retainer structure may optionally include an adjustable couplingoperable between an unlocked condition in which an angular position ofthe shield is adjustable to a user-selected position, and a lockedcondition in which the angular position of the shield is substantiallyfixed. Additionally or alternatively, the radiation shield mayoptionally have a contoured shape providing a skewed reverse curveprofile along its height. Additionally or alternatively, the radiationshield may optionally comprise a material having radiation shieldingproperties (such as barium sulfate), and the radiation shield may have adensity of about 1.5 g/cm³ to about 2.5 g/cm³.

In some embodiments, a radiation shielding device may include aradiation shield having a height of about 5 cm to about 25 cm and amaximum thickness of about 1 mm to about 5 mm. Also, the radiationshield can comprise a material having radiation shielding properties.The device may also include a base that includes a substructureattachable to an object, and a retainer structure attachable to theradiation shield.

The details of several embodiments are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages of the invention will be apparent from the description anddrawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-C are perspective front, perspective rear, and top views of ashielding device in accordance with some embodiments.

FIG. 2 is an exploded perspective view of the shielding device of FIGS.1A-C.

FIG. 3A is a cross-sectional view of the shielding device of FIGS. 1A-C.

FIG. 3B is a cross-sectional view of a portion of the shielding deviceof FIG. 3A.

FIGS. 4A-C are perspective rear, side, and rear views of the shieldingdevice of FIGS. 1A-C illustrated with the shield at an anglednon-orthogonal position relative to the base.

FIG. 5A is a perspective rear view of another shielding device inaccordance with some alternative embodiments.

FIG. 5B is an exploded perspective rear view of the shielding device ofFIG. 5A.

FIGS. 6A-B are side and perspective views of a shield device inaccordance with additional embodiments.

FIGS. 6C-D are side and perspective views of a shield device inaccordance with further embodiments.

FIGS. 6E-F are side and perspective views of a shield device inaccordance with additional embodiments.

FIGS. 6G-H are side and perspective views of a shield device inaccordance with further embodiments.

FIGS. 6I-J are side and perspective views of a shield device inaccordance with additional embodiments.

FIGS. 6K-L are side and perspective views of a shield device inaccordance with further embodiments.

FIG. 7 is an exploded perspective front view of a second alternativeshielding device in accordance with some embodiments.

FIG. 8 is an exploded perspective front view of a third alternativeshielding device in accordance with some embodiments.

FIG. 9 is a flow chart describing a process of using a shielding devicein accordance with some embodiments.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1A-C, some embodiments of a shielding device 100 caninclude a base 102 and a shield 104 coupled to the base 102. Theshielding device 100 can be used to provide protection for a healthcareworker (e.g., physician, nurse, technician) during a medical procedure.As one example, the base 102 of the shielding device 100 can be adheredto a patient's skin positioned near the patient's liver when inserting abile drain using real-time X-Ray imaging. In such circumstances, theshield 104 can be manipulated to a user-selected orientation relative tothe base 102 and then locked in the selected position so as to provide aradiation block for the healthcare worker's hands that would otherwisebe within the radiation field from the real-time X-Ray imagingapparatus. In addition to the shielding device 100 protecting thehealthcare worker's hands from X-Ray radiation, the shield 104 canfurther provide physical protection for the healthcare worker fromspatter of blood or other bodily fluids that may occur during theprocedure—all while allowing the healthcare worker to position his orher hands in a non-disruptive and ergonomically effective manner.

In some applications, protecting portions of the healthcare worker'sbody nearest to the source of radiation, such as the worker hands, canbe beneficial because radiation exposure decreases based on the distancefrom the source. Thus, a healthcare worker's hands, if not protected,may be exposed to nine times the radiation to which his/her torso isexposed during an X-Ray imaging procedure. In some applications, theshielding device 100 is provided as a portable structure that can betransported to the site of a medical procedure (e.g., an exam room or anoperating room) by the healthcare worker and disposed of at theconclusion of the procedure to prevent the transmission of pathogensbetween patients and/or healthcare workers.

As shown, the base 102 of the shielding device 100 includes asubstructure 106 and a retainer structure 108. During use of theshielding device 100, the substructure 106 supports the base 102 on thesurface of an object (not shown) and the retainer structure 108 couplesthe base 102 to the shield 104. In various applications of the shieldingdevice 100, the supporting object may include a portion of the patient'sskin along an exposed body part of the patient (e.g., a limb or a torso)or any other object that is capable of firmly carrying the base 102 andthe attached shield 104 (e.g., a table, a bed rail, or the like). Insome applications, the supporting object may include a portion of thehealthcare worker's body, e.g., a hand or an arm.

The construction of the substructure 106 provides sufficient mechanicalstrength and stiffness for supporting the base 102 on the surface of theobject in a substantially fixed position during use (e.g., as the shield104 is being coupled to the base 102 or otherwise manipulated by ahealthcare worker). In this embodiment, the substructure 106 includes abutterfly-shaped, generally flat member having a circular central body110 extended by opposing oval-shaped wings 112. The central body 110 ofthe substructure 106 is attached to the retainer structure 108 (and,optionally, can be continuous such that it extends under the entirety ofthe retainer structure 108 (refer to FIG. 2)). The wings 112 provideadditional surface area for contacting the supporting object (e.g., soas to more firmly adhere or otherwise attached with the patient's skinor other supporting object). In some embodiments, the substructure 106can include a compliant member capable of conforming to various contoursand corners of the supporting object. For example, in this embodiment,the wings 112 can be bent out of plane to follow the shape of theobject. In some embodiments, the substructure 106 can include amalleable wire frame to reinforce the compliant member.

In some embodiments, the substructure 106 is fabricated from one or moreplastic materials capable of accepting an infusion of radiationshielding material (e.g., material including barium, lead, tungsten,tin, aluminum and/or any attenuating metal). In some embodiments, thesubstructure 106 can include a laminated multi-layer construction. Forexample, the substructure 106 can include a skin-friendly underlayer(e.g., a foam layer) bonded to a reinforcing overlayer (e.g., a flexiblemetal or plastic layer). In some embodiments, the substructure 106 isfabricated from one or more materials that are suitable for medicalapplications (e.g., biocompatible metallic and/or polymeric materials).For example, the substructure 106 can be fabricated from a medical gradedense foam sheet material having a thickness of about 1 millimeter to2.5 centimeters. In some embodiments, a bottom surface 114 of thesubstructure 106 can include an adhesive material suitable fortemporarily adhering the base 102 to the supporting object. The adhesivecan be a medical grade adhesive that is resistant to water, blood, andother bodily fluids, and that is suitable for adhering to the exteriorof a targeted skin surface. In some embodiments, the adhesive on thebottom surface 114 may initially be covered by a removable sheet toexpose the adhesive for use. Various types of suitable attachmentmechanisms can be used to couple the substructure 106 to the supportingobject. For example, in some embodiments, the substructure can include asuction device or an adjustable strap system to attach the substructureto the object. In some embodiments, the substructure can be provided inthe form of a glove or a strap system wearable by the healthcare workerwhile performing a medical procedure (e.g., a fluoroscopic diagnosticprocedure to evaluate for aspiration).

As noted above, the retainer structure 108 couples the base 102 to theshield 104 during use. In some embodiments, the retainer structure 108provides an adjustable coupling that permits movement of the shield 104with at least two degrees of freedom (and, in some embodiments, threedegrees of freedom). As such, the shield can be positioned at numerousangles relative to the substructure 106 of the base 102 (and thereforethe supporting object). In some embodiments, the coupling of theretainer structure 108 can be operated between an unlocked condition,where the angular position of the shield 104 is adjustable to auser-selected position, and a locked condition, where the angularposition of the shield 104 is fixed.

Referring to FIGS. 2, 3A and 3B, the retainer structure 108 includes aplatform 116, a first yoke 118 a, a second yoke 118 b, a pilot member120, a clamp member 122, and a lock knob 124. The platform 116 is acircular frame fixedly attached to the central body 110 of thesubstructure 106. As shown, each of the first and second yokes 118 a,118 b is a semi-spherical segment having an elongated slot 126 a, 126 bextending along the length of the segment. The first and second yokes118 a, 118 b are oriented perpendicular to one another and positioned inan overlapping manner, such that the slots 126 a, 126 b meet at anintersection point of the yokes 118 a, 118 b. The diametrically opposedends 128 a, 128 b of the first and second yokes 118 a, 118 b arerotationally mounted to the platform 116 in a fixed position. Thus, thefirst yoke 118 a is constrained to pivotal movement in a first direction130 a with respect to the platform 116; and the second yoke 118 b ispivotally movable in a second direction 130 b that is perpendicular tothe first direction 130 a.

Referring to FIG. 3B, the pilot member 120 includes a central shaft 132and a convex flange 134 extending radially outward to surround the shaft132. The shaft 132 defines a central threaded bore 136. The convexflange 134 provides a sloping upper flange surface with curvature toaccommodate the semi-spherical shape of the first and second yokes 118a, 118 b. The pilot member 120 is located with the convex flange 134positioned beneath the first and second yokes 118 a, 118 b and an upperportion of the shaft 132 projecting through the intersection point ofthe slots 126 a, 126 b. The clamp member 122 is coupled with the pilotmember 120 to retain the pilot member 120 at the intersection point ofthe slots 126 a, 126 b. The clamp member 122 includes a central opening138 and a concave flange 135 extending radially outward to surround theopening 138. The concave flange 135 provides a sloping lower flangesurface with curvature to accommodate the semi-spherical shape of thefirst and second yokes 118 a, 118 b. The clamp member 122 is locatedwith the concave flange 135 positioned above the first and second yokes118 a, 118 b. The upper portion of the shaft 132 of the pilot member 120projects longitudinally into the opening 138 of the clamp member 122. Tocouple the clamp member 122 to the pilot member 120, a radial lip 139 atthe upper end of the shaft 132 of the pilot member 120 provides a snapengagement with a radial shoulder 140 in the opening 138 of the clampmember 122.

Still referring to FIG. 3B, the lock knob 124 includes a shank 141 andhead 142. The head 142 includes three flanges 144 a, 144 b, 144 c,extending radially outward to surround a cylindrical body 143 coaxiallyaligned with the shank 141. The flanges 144 a, 144 b, 144 c aresubstantially flat and spaced apart from one another longitudinallyalong the body 143. A lower portion of the shank 141 is threaded. Theshank 141 projects longitudinally into the opening 138 of the clampmember 122 and the central bore of the shaft 132 of the pilot member120. The threads of the central bore of the shaft 132 of the pilotmember 120 mate with the threads at the lower portion of the shank 141of the lock knob 124. Thus, the lock knob 124 is telescopically coupledwith the pilot member 120 and the clamp member 122.

The lock knob 124 is movable with two degrees of freedom relative to thesubstructure 106 in the directions 130 a, 130 b permitted by the firstand second yokes 118 a, 118 b. Movement of the lock knob 124 causesidentical movement of the coupled pilot member 120. Movement of thepilot member 120 driven by the lock knob 124 causes movement by thefirst and second yokes 118 a, 118 b as the shaft 132 of the pilot member120 interacts with the slots 126 a, 126 b. For example, as the pilotmember 120 moves through the slot 126 a of the first yoke 118 b, thesecond yoke 118 b is pulled by the shaft 132 to pivot in the seconddirection 130 b; and vice versa. The length of the slot 126 a, 126 b ineach respective yoke 118 a, 118 b bounds the movement of the pilotmember 120, and therefore the lock knob 124. Freedom in the pivotingdirections 130 a, 130 b permits the lock knob 124 to execute 360°circumduction movement resembling the conical movement of a joystick.

Still referring to FIG. 3B, the shield 104 is attached to the lock knob124 by two grippers 146 a, 146 b that extend outward from the rear side148 of the shield 104 to engage with the head 142 of the lock knob 124.Each of the grippers 146 a, 146 b includes a pair of opposing fingersformed to reach between the flanges 144 b, 114 c to grip the body 143 ofthe head 142. As shown, the first gripper 146 a is positioned betweenthe flanges 144 b and 144 c of the lock knob 124; and the second gripper146 b is positioned below the flange 144 c. In some embodiments, thegrippers 146 a, 146 b loosely grip the body 143 to allow 360° ofrotational movement 149 in a direction about a central axis of the lockknob 124. The shield 104 can also be tilted at various angles relativeto the substructure 106 by circumduction movement of the lock knob 124.FIGS. 4A-C illustrate the shield 104 tilted at an angle that is forwardand sideways relative to the stationary substructure 106 of the base102.

In some embodiments, the previously described movements of the shield104 are permitted while the retainer structure 108 is in an unlockedcondition, and prevented while the retainer structure 108 is in a lockedcondition. In this embodiment, the retainer structure 108 can beoperated from the unlocked condition to the locked condition byadjusting the lock knob 124. For example, the lock knob 124 can berotated (e.g., clockwise or counter clockwise) to telescopically advancethe shank 141 downward through the shaft 132 of the pilot member 120 viathe mating threads. Downward movement of the lock knob 124 relative tothe pilot member 120 and the clamp member 122 urges the bottommostgripper 146 b of the shield 104 toward the rim 150 of the opening 138 ofthe clamp member 122. As the lock knob 124 continues to advancedownward, the clamp member 122 is pressed down against the first andsecond yokes 118 a, 118 b. The first and second yokes 118 a, 118 b areclamped between the concave flange 135 of the clamp member 122 and theconvex flange 134 of the pilot member 120, and therefore held in a fixedposition by frictional forces. With the first and second yokes 118 a,118 b held stationary, circumduction movement of the lock knob 124 isprevented. Likewise, the first gripper 146 a becomes clamped between theflanges 144 b and 144 c of the lock knob 124; and the second gripper 146b becomes clamped between the flanges 144 c of the lock knob 124 and therim 140 of the clamp member 122. Thus, frictional forces also preventrotation of the shield 104 about the central axis of the lock knob 124.As should be understood from FIGS. 1A-4C, the shield 104 can berepeatedly operated between the locked condition and the unlockedcondition (by adjusting the lock knob 124) so that the shield 104 islocked into different user-selected orientations relative to the base102 throughout a medical procedure.

As noted above, the shield 104 can also act as a physical barrier toprotect the healthcare worker. Referring to back FIGS. 1A-C, the outeredges of the shield 104 define an overall size of the shield104—including a height “H,” a width “W”—and a thickness “T” (FIG. 1A).In some embodiments, the shield 104 is provided having a contouredshape. In some embodiments, the contoured shape of the shield 104 canprovide enhanced splash and spatter protection to inhibit liquids (e.g.,blood and other bodily fluids) from contacting the healthcare workerduring a medical procedure while simultaneously providing an ergonomicspace for the healthcare worker to position his/her hands during use. Inthis embodiment, the shield 104 has a skewed reverse curve profile alongits height, defining a short outwardly projecting lip 152 at the top ofthe shield 104 and an arcuate midsection 154 (FIG. 1B). During use, theshield 104 can be positioned with the front side 156 of the shield 104facing the healthcare worker and the rear side 158 of the shield 104facing a radiation source. In this orientation, the lip 152 and themidsection 154 are directed away from the healthcare worker to provideliquid splash and spatter protection. Further, because the midsection154 of the shield 104 bows outward away from the healthcare worker,there is additional space for the healthcare worker to maneuver his/herhands (e.g., to perform a medical procedure and/or to adjust the lockknob 124). In this embodiment, the shield 104 is also contouredwidthwise (convex from the front side 156 of the shield 104) to curvearound the space where the healthcare worker is expected to positionhis/her hands (FIG. 1C). This configuration may provide additionalprotection for the healthcare worker around the space where thehealthcare worker positions his/her hands. Notches 160 are provided nearthe bottom of the shield 104 to receive a tubular work piece (e.g., acatheter) installed on a patient (FIG. 1A).

In some embodiments, the shield 104 is capable of attenuating ordeflecting the flux of electromagnetic radiation (e.g., X-Ray radiation)directed at the shield 104 by a radiation source (not shown). Theeffectiveness of the shield 104 directly corresponds to the radiationshielding properties of the materials used to fabricate the shield 104.The required radiation shielding effectiveness of the shield 104 mayvary across different applications. For example, a less effective shieldmay be used applications where the healthcare worker is farther awayfrom the radiation source, and vice versa. In some embodiments, theshield 104 can include one or more layers of radiation shieldingmaterial (e.g. a sheet of lead foil). For example, such radiationshielding layers can be sandwiched between plastic or metalreinforcement layers. In some embodiments, the shield 104 can befabricated from a plastic material infused with suitable radiationshielding materials (e.g., materials including barium, lead, tungsten,tin, aluminum and/or any attenuating metal).

As described above, the shield 104 is carried by various components ofthe retainer structure 108. So, as practical matter, a tolerable weightof the shield 104 may be affected by the load bearing capacity of theretainer structure 108. Further, in applications where, for example, theshielding device 100 is supported directly on a body part of thepatient, the tolerable weight of the shield 104 may be selected so as toreduce excessive strain on the patient's skin or other body part.

Factors that may be considered in designing a shield 104 of suitableweight include the volume of the shield 104 and the density of thefabricating materials. The weight of the shield 104 increases withincreasing volume and/or density. The volume of the shield 104 variesaccording to its surface area and thickness. The volume of the shield104 can be varied without affecting the overall size (i.e., the height“H,” the width “W”), for example, by adjusting the degree of curvatureof the contours (e.g., the lip 152, the midsection 154, and thewidthwise contour) and/or by adjusting the thickness of the shield 104.In some applications, it may be advantageous to maintain a relativelarge overall size of the shield 104 to provide adequate protection tothe healthcare worker. The density of the shield 104 can vary based onthe specific type and amount of radiation shielding material used. Forexample, barium sulfate is approximately two-thirds less dense thanlead, and therefore would provide a less dense, and lighter, shield ifall other conditions (e.g., the volume of the shield and/or the otherfabrication materials) are equal. As such, in some embodiments, theshield may comprise a material such as barium sulfate or another heavymetal material suitable for reducing or blocking radiation exposure.

In this embodiment, the volume of the shield is about 50 cm³ to about100 cm³ (preferably about 71 cm³ in the depicted example), and isfabricated from a plastic material infused with barium sulfate, whichprovides a shield density of about 1.5 g/cm³ to about 2.5 g/cm³(preferably about 2.0 g/cm′ in the depicted example). The height of theshield is about 5 cm to about 25 cm (preferably about 15 cm in thedepicted example); the mass of the shield is about 100 g to about 200 g(preferably about 142 g in the depicted example); the thickness of theshield is about 1 mm to about 5 mm (preferably about 2.3 mm in thedepicted example); the radius of curvature of the lip of the shield isabout 5 mm to about 10 mm (preferably about 7.7 mm in the depictedexample); the radius of curvature of the midsection of the shield isabout 3 cm to about 10 cm (preferably about 5.1 cm in the depictedexample); and the radius of curvature of the widthwise contour is about10 cm to about 25 cm (preferably about 17.7 cm in the depicted example).In this embodiment, the shield weighs about 0.1 lbs to about 0.5 lbs(preferably about 0.3 lbs in the depicted example).

FIGS. 5A and 5B depict a shielding device 500 that is similar to theshielding device 100, including a base 502 and a shield 504 coupled tothe base 502. In this embodiment, the contours of the shield 504 aresignificantly more pronounced compared to the shield 104. In particular,the lip 552 and the midsection 554 have a significantly greater degreeof curvature, creating a greater surface area and therefore a greatervolume (assuming constant overall size and thickness). Thus, if allother conditions are equal, the shield 504 would have a greater weightthan the shield 104.

The base 502 includes a substructure 506 and a retainer structure 508.In this embodiment, the substructure 506 includes four radial legs 512.In some embodiments, the legs 512 are flexible and can be bent out ofplane to follow the shape of a supporting object. The retainer structure508 includes a platform 516, a first yoke 518 a, a second yoke 518 b, apilot member 520, a clamp member 522, and a lock knob 524. Generally,these components may be assembled to function generally as describedabove. However, in this embodiment, the shield 504 is coupled to thelock knob 524 by a coupling pin 562. In particular, the lock knob 524includes a central bore for receiving the lower end of the coupling pin562; and the upper end of the coupling pin 562 is received by a collarhousing 564 on the rear side 548 of the shield 504.

FIGS. 6A-6L depict various example shields 604 a-604 f that may besuitable for use in various embodiments of a suitable shielding device.As described above, the overall shape and size, as well as the contoursof the various shields 604 a-604 f may affect the volume, and thereforethe weight, of the respective shield for a given density of thefabricating materials. The configuration of the shield (e.g., the size,shape, contour, thickness, density) may vary across differentimplementations based on the desired application. For example,applications requiring protection from a relative high degree of scatterradiation may involve a shield that is relatively large in overall sizeto provide broad coverage. In this case, the weight of the shield can bemaintained within tolerable limits, for example, by fabricating theshield with a less dense material and/or by fabricating the shield withless severe counters and/or relatively low thickness.

FIG. 7 depicts yet another shielding device 700 including a base 702 anda shield 704 coupled to the base 702. The shield 704 is similar to theshield 104, having a contoured shape defining a reverse curve profileincluding an outwardly projecting lip 752 and an arcuate midsection 754.The shield 704 is also contoured widthwise, appearing convex from thefront side 756 of the shield 704. As noted above, in some embodiments,the contoured shape of the shield 704 can provide splash and spatterprotection to inhibit liquids from contacting the healthcare worker.Further, in some embodiments, the contoured shape of the shield 704 canprovide an ergonomic space for the healthcare worker to position his/herhands during use.

The base 702 includes a substructure 706 and a retainer structure 708.As in previous embodiments, during use of the shielding device 700, thesubstructure 706 supports the base 702 on the surface of an object (notshown) and the retainer structure 708 couples the base 702 to the shield704. In this embodiment, the substructure 706 includes abutterfly-shaped member having opposing tapered oblong wings 712connected by a narrow body 710. In some embodiments, the substructure706 can include a compliant member capable of conforming to variouscontours and corners of the supporting object. For example, in thisembodiment, the wings 712 can be bent out of plane to follow the shapeof the object. In some embodiments, the substructure 706 can include amalleable wire frame to reinforce the compliant member. In someembodiments, the substructure 706 is fabricated from one or morematerials that are suitable for medical applications (e.g.,biocompatible metallic and/or polymeric materials). In some embodiments,a bottom surface 714 of the substructure 706 can include an adhesivematerial suitable for temporarily adhering the base 702 to thesupporting object. The adhesive can be a medical grade adhesiveresistant to water, blood, and other bodily fluids, and releasable byalcohol (e.g., ethyl alcohol). In some embodiments, the substructure 706is fabricated from one or more materials capable of accepting aninfusion of radiation shielding material (e.g., material includingbarium, lead, tungsten, tin, aluminum and/or any attenuating metal). Insome embodiments, the substructure 706 can include a laminatedmulti-layer construction. For example, the substructure 706 can includea skin-friendly underlayer (e.g., a foam layer) bonded to a reinforcingoverlayer (e.g., a flexible metal or plastic layer).

As shown, the substructure 706 further includes a plurality of apertures766 that extend through the material to expose the supporting object.During use, a healthcare worker can suture the substructure 706 to theobject through one or more of the apertures 766, for example, if theadhesive on the bottom surface 714 is unsuitable of ineffective for theparticular applications. As one example, the healthcare worker cansuture the substructure to a patient's skin through the apertures 766 ifthe patient is allergic to the adhesive.

The retainer structure 708 is attached to the substructure 706 acrossthe narrow body 710 between the wings 712. The retainer structure 708can be attached to a coupling member 768 provided at the bottom end ofthe shield 704 to couple the shield 704 to the base 702. In someembodiments, the coupling member 768 can be snap-fit or press-fit to theretainer structure 708 to secure the shield 704 to the base 702. In thisembodiment, the retainer structure 708 includes a slot 770 appropriatelyshaped and sized for receiving a tubular work piece (e.g., a catheter, adrain, an intravenous line) and a lock mechanism 772 for securing thework piece in the slot 770. For example, if shielding device 700 issupported on an object proximate a catheter exit site, the catheter canbe positioned lengthwise in the slot 770 and held in place by the lockmechanism 772 to inhibit the unintentional release of the catheter fromthe patient. The slot 770 and the lock mechanism 772 can be designed toaccommodate a particular size or a range of sizes. In some embodiments,the slot 770 and the lock mechanism 772 are designed to accommodatetubular work pieces in the range of about 4 French (1.33 mm) to about 12French (4 mm). In some embodiments, the lock mechanism 772 includes aspring-loaded clamp (not shown) that grips the work piece withsufficient force to inhibit unintentional release of the work piece. Insome embodiments, the work piece can be secured and/or released from thelock mechanism 772 without removing the shield 704 from the base 702,which may allow the healthcare worker to adjust the work piece during amedical procedure without being exposed to radiation. In someembodiments, a shielding plug (not shown) can be installed on theretainer structure 708 to block fluid and/or radiation from penetratingthrough the slot 770 and the lock mechanism 772 when no work piece ispresent.

FIG. 8 depicts a shielding device 800 that is similar to the shieldingdevice 700, including a base 802 and a shield 804 coupled to the base802 In this embodiment, the shield 804 is mounted to a coupling member868 by a ball and socket joint 874. The coupling member 868 attaches theshield 804 to the retainer structure 808 of the base 802. The ball andsocket joint 874 permits movement of the shield 804 relative to the base802 within at least two degrees of freedom. In this embodiment, the balland socket joint 874 permits rotational movement 876 of the shield 804about an axis 878 substantially perpendicular to the base 802, andarticulating movement 880 about an axis 882 substantially perpendicularto the axis of rotation. As shown, the articulating movement 880 tiltsthe shield 804 forward and backward relative to the base 802. In someembodiments, the ball and socket joint 874 permits 360° of rotation ofthe shield 804. In some embodiments, the ball and socket joint 874limits articulation of the shield 804 to plus or minus 30°.

Referring now to FIG. 9, a suitable shielding device (e.g., shieldingdevice 100, 500, 700 and 800) can be operated (e.g., by a healthcareworker) to implement a process 900 of shielding radiation and/or liquidfrom a healthcare worker during a medical procedure. Note that theprocess 900 does not require the particular order of operations shown inFIG. 9 and described below to achieve desirable results. In addition,other operations may be provided, or eliminated, to the process 900without departing from the scope of the present disclosure.

In operation 910, a base of the shielding device can be coupled to anobject. The object may include an exposed body part of a patient or anyother structure that is capable of carrying the base and an attachedshield. In some embodiments, the base can be coupled to the object by anadhesive layer on a bottom surface of the base. In some embodiments, thebase can be sutured to the object.

In operation 920, a shield of the shielding device can be coupled to thebase. For example, the shield can be attached to a retainer structure ofthe base. In some embodiments, the retainer structure may include a lockknob and the rear side of the shield can include grippers that engagethe head of the lock knob (e.g., shielding device 100). In someembodiments, the shield can be coupled to the lock knob by a couplingpin (e.g., shielding device 500). The lower end of the coupling pin isreceived in a central bore of the lock knob, and the upper end of thecoupling pin is received by a collar housing on the rear side of theshield. In some embodiments, a coupling member at the bottom end of theshield can be press-fit or snap-fit to the retainer structure (e.g.,shielding device 700). In some embodiments, a malleable stem or a claspcan be used to couple the shield to the base.

Optionally, in operation 930, the angle of the shield relative to thebase of the shielding device and the object can be adjusted. In someembodiments, the coupling between the shield and the base permitsmovement of the shield within three degrees of freedom relative to thebase (e.g., shielding device 100). In this case, the angle of the shieldrelative to the base can be adjusted by rotation and circumductionmovement of the shield relative to the base. In some embodiments, thecoupling permits movement of the shield within at least two degrees offreedom (e.g., shielding device 800). In this case, the angle of theshield relative to the base can be adjusted by rotation and articulationmovement of the shield relative to the base. Optionally, in operation940, the shield can be locked in place at the angle. For example, inembodiments where the shield includes a lock knob threaded to a pilotmember (e.g., shielding device 100 and 500), the lock knob can berotated to clamp the shield in place.

In operation 950, the medical procedure can be conducted while theshield inhibits radiation and/or liquid from contacting the healthcareworker. In some embodiments, the shield can be fabricated from one ormore suitable radiation shielding materials. In some embodiments, theshield can be appropriately contoured to block liquid splash andsplatter that may occur during the medical procedure. Optionally, inoperation 960, the shielding device is removed from the supportingobject and disposed of, for example, to prevent the spreading ofpathogens between patients and/or healthcare workers.

The use of terminology such as “front,” “rear,” “top,” “bottom,” “over,”“above,” and “below” throughout the specification and claims is fordescribing the relative positions of various components of the systemand other elements described herein. Similarly, the use of anyhorizontal or vertical terms to describe elements is for describingrelative orientations of the various components of the system and otherelements described herein. Unless otherwise stated explicitly, the useof such terminology does not imply a particular position or orientationof the system or any other components relative to the direction of theEarth gravitational force, or the Earth ground surface, or otherparticular position or orientation that the system other elements may beplaced in during operation, manufacturing, and transportation.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention.

1. A radiation shielding device, comprising: a radiation shield,comprising: a bottom portion including at least one notch configured toreceive a tubular work piece installed on a patient; and a basecomprising: a substructure attachable to an object; and a retainerstructure attachable to the radiation shield, wherein the retainerstructure comprises an adjustable coupling operable between an unlockedcondition in which an angular position of the shield is adjustable to auser-selected position, and a locked condition in which the angularposition of the shield is substantially fixed.
 2. The radiationshielding device of claim 1, wherein the adjustable coupling permitsmovement of the shield with at least two degrees of freedom.
 3. Theradiation shielding device of claim 1, wherein the permitted movement ofthe shield includes circumduction movement.
 4. The radiation shieldingdevice of claim 1, wherein the radiation shield has a contoured shapeproviding a skewed reverse curve profile along its height.
 5. Theradiation shielding device of claim 1, wherein the radiation shielddefines an outwardly projecting lip at the top of the shield and a broadarcuate midsection.
 6. The radiation shielding device of claim 5,wherein a radius of curvature of the lip of the shield is about 5 mm toabout 10 mm, and the radius of curvature of the midsection is about 3 cmto about 10 cm.
 7. The radiation shielding device of claim 4, whereinthe shield is contoured widthwise in a convex orientation relative to afront side of the shield.
 8. The radiation shielding device of claim 1,wherein an overall size of the shield is sufficient to cover an areawhere a healthcare worker would position his/her hands during a medicalprocedure.
 9. The radiation shielding device of claim 8, wherein theradiation shield has a density of about 1.5 g/cm³ to about 2.5 g/cm³,has volume of about 50 cm³ to about 100 cm³, and has a mass of about 100g to about 200 g.
 10. The radiation shielding device of claim 8, whereinthe radiation shield has a width greater than a height and a thickness.11. The radiation shielding device of claim 8, wherein the shield has aheight of about 5 cm to about 25 cm and a maximum thickness of about 1mm to about 5 mm.
 12. The radiation shielding device of claim 1, whereinthe radiation shield comprises a barium sulfate, and the radiationshield has a nominal density of about 1.5 g/cm³ to about 2.5 g/cm³. 13.The radiation shielding device of claim 1, wherein the shield comprisesa plastic material infused with barium sulfate.
 14. The radiationshielding device of claim 1, wherein the shield comprises one or moresheets formed from a layer comprising barium sulfate.
 15. The radiationshielding device of claim 1, wherein the base is configured to becoupled to a supporting object.
 16. The radiation shield device of claim15, wherein the base comprises an adhesive layer for removably adheringthe base to the supporting object.
 17. A radiation shielding device,comprising: a radiation shield, wherein the shield has a height of about5 cm to about 25 cm and a maximum thickness of about 1 mm to about 5 mm,and a contoured shape providing a skewed reverse curve profile along itsheight; and a base comprising: a substructure attachable to an object;and a retainer structure attachable to the radiation shield, wherein theretainer structure comprises an adjustable coupling operable between anunlocked condition in which an angular position of the shield isadjustable to a user-selected position, and a locked condition in whichthe angular position of the shield is substantially fixed, and whereinthe base comprises an adhesive layer for removably adhering the base toa supporting object.
 18. The radiation shielding device of claim 17,wherein the permitted movement of the shield includes circumductionmovement.
 19. The radiation shielding device of claim 18, wherein theradiation shield defines an outwardly projecting lip at the top of theshield and a broad arcuate midsection, and wherein a radius of curvatureof the lip of the shield is about 5 mm to about 10 mm, and the radius ofcurvature of the midsection is about 3 cm to about 10 cm.
 20. Theradiation shielding device of claim 19, wherein the radiation shield hasa width greater than a height and a thickness, and wherein the shieldhas a height of about 5 cm to about 25 cm and a maximum thickness ofabout 1 mm to about 5 mm.